Airway implant and methods of making and using

ABSTRACT

An airway implant device for maintaining and/or creating an opening in air passageways is disclosed. Methods of using the device are also disclosed. The airway implant device comprises a deformable element to control the opening of an air passageway. Preferably the deformable element is an electroactive polymer element. Energizing of the electroactive polymer element provides support for the walls of an air passageway, when the walls collapse, and thus, completely or partially opens the air passageway. Methods of treating airway disorders such as sleep apnea and snoring with the airway implant device are disclosed herein.

CROSS-REFERENCE

This application is a continuation in part of U.S. patent applicationSer. No. 10/946,435, filed Sep. 21, 2004, which is incorporated hereinby reference in its entirety.

BACKGROUND OF THE INVENTION Background

Snoring is very common among mammals including humans. Snoring is anoise produced while breathing during sleep due to the vibration of thesoft palate and uvula. Not all snoring is bad, except it bothers the bedpartner or others near the person who is snoring. If the snoring getsworst overtime and goes untreated, it could lead to apnea.

Those with apnea stop breathing in their sleep, often hundreds of timesduring the night. Usually apnea occurs when the throat muscles andtongue relax during sleep and partially block the opening of the airway.When the muscles of the soft palate at the base of the tongue and theuvula relax and sag, the airway becomes blocked, making breathinglabored and noisy and even stopping it altogether. Sleep apnea also canoccur in obese people when an excess amount of tissue in the airwaycauses it to be narrowed.

In a given night, the number of involuntary breathing pauses or “apneicevents” may be as high as 20 to 60 or more per hour. These breathingpauses are almost always accompanied by snoring between apnea episodes.Sleep apnea can also be characterized by choking sensations.

Sleep apnea is diagnosed and treated by primary care physicians,pulmonologists, neurologists, or other physicians with specialtytraining in sleep disorders. Diagnosis of sleep apnea is not simplebecause there can be many different reasons for disturbed sleep.

The specific therapy for sleep apnea is tailored to the individualpatient based on medical history, physical examination, and the resultsof polysomnography. Medications are generally not effective in thetreatment of sleep apnea. Oxygen is sometimes used in patients withcentral apnea caused by heart failure. It is not used to treatobstructive sleep apnea.

Nasal continuous positive airway pressure (CPAP) is the most commontreatment for sleep apnea. In this procedure, the patient wears a maskover the nose during sleep, and pressure from an air blower forces airthrough the nasal passages. The air pressure is adjusted so that it isjust enough to prevent the throat from collapsing during sleep. Thepressure is constant and continuous. Nasal CPAP prevents airway closurewhile in use, but apnea episodes return when CPAP is stopped or it isused improperly. Many variations of CPAP devices are available and allhave the same side effects such as nasal irritation and drying, facialskin irritation, abdominal bloating, mask leaks, sore eyes, andheadaches. Some versions of CPAP vary the pressure to coincide with theperson's breathing pattern, and other CPAPs start with low pressure,slowly increasing it to allow the person to fall asleep before the fullprescribed pressure is applied.

Dental appliances that reposition the lower jaw and the tongue have beenhelpful to some patients with mild to moderate sleep apnea or who snorebut do not have apnea. A dentist or orthodontist is often the one to fitthe patient with such a device.

Some patients with sleep apnea may need surgery. Although severalsurgical procedures are used to increase the size of the airway, none ofthem is completely successful or without risks. More than one proceduremay need to be tried before the patient realizes any benefits. Some ofthe more common procedures include removal of adenoids and tonsils(especially in children), nasal polyps or other growths, or other tissuein the airway and correction of structural deformities. Younger patientsseem to benefit from these surgical procedures more than older patients.

Uvulopalatopharyngoplasty (UPPP) is a procedure used to remove excesstissue at the back of the throat (tonsils, uvula, and part of the softpalate). The success of this technique may range from 30 to 60 percent.The long-term side effects and benefits are not known, and it isdifficult to predict which patients will do well with this procedure.

Laser-assisted uvulopalatoplasty (LAUP) is done to eliminate snoring buthas not been shown to be effective in treating sleep apnea. Thisprocedure involves using a laser device to eliminate tissue in the backof the throat. Like UPPP, LAUP may decrease or eliminate snoring but noteliminate sleep apnea itself. Elimination of snoring, the primarysymptom of sleep apnea, without influencing the condition may carry therisk of delaying the diagnosis and possible treatment of sleep apnea inpatients who elect to have LAUP. To identify possible underlying sleepapnea, sleep studies are usually required before LAUP is performed.

Somnoplasty is a procedure that uses RF to reduce the size of someairway structures such as the uvula and the back of the tongue. Thistechnique helps in reducing snoring and is being investigated as atreatment for apnea.

Tracheostomy is used in persons with severe, life-threatening sleepapnea. In this procedure, a small hole is made in the windpipe and atube is inserted into the opening. This tube stays closed during wakinghours and the person breathes and speaks normally. It is opened forsleep so that air flows directly into the lungs, bypassing any upperairway obstruction. Although this procedure is highly effective, it isan extreme measure that is rarely used.

Patients in whom sleep apnea is due to deformities of the lower jaw maybenefit from surgical reconstruction. Surgical procedures to treatobesity are sometimes recommended for sleep apnea patients who aremorbidly obese. Behavioral changes are an important part of thetreatment program, and in mild cases behavioral therapy may be all thatis needed. Overweight persons can benefit from losing weight. Even a 10percent weight loss can reduce the number of apneic events for mostpatients. Individuals with apnea should avoid the use of alcohol andsleeping pills, which make the airway more likely to collapse duringsleep and prolong the apneic periods. In some patients with mild sleepapnea, breathing pauses occur only when they sleep on their backs. Insuch cases, using pillows and other devices that help them sleep in aside position may be helpful.

Recently, Restore Medical, Inc., Saint Paul, Minn. has developed a newtreatment for snoring and apnea, called the Pillar technique. PillarSystem is a procedure where 2 or 3 small polyester rod devices areplaced in the patient's soft palate. The Pillar System stiffens thepalate, reduces vibration of the tissue, and prevents the possibleairway collapse. Stiff implants in the soft palate, however, couldhinder patient's normal functions like speech, ability to swallow,coughing and sneezing. Protrusion of the modified tissue into the airwayis another long-term concern.

As the current treatments for snoring and/or apnea are not effective andhave side-effects, there is a need for additional treatment options.

BRIEF SUMMARY OF THE INVENTION

Methods and devices for the treatment of airway disorders, such assnoring and/or apnea are disclosed herein. The device described hereincomprises a deformable element. The deformable element is partially orcompletely implanted in an airway passageway wall or adjacent to an airpassageway wall to treat the improper opening and closing of thepassageway. In preferred embodiments, the deformable element is anelectroactive polymer (EAP) element. The deformable element is typicallyinserted into the soft palate and/or sidewalls of the patient's airway.In one embodiment, the EAP element has a low stiffness under normalconditions. The EAP element is energized when the opening of the airpassageway has to be maintained open, such as during sleep. When the EAPelement is energized, the polymer stiffens and tends to deform and thushas the ability to support the weight of the soft palate and sidewallsof the air ways and open the air passageways. When the charge isremoved, the EAP element becomes soft and tends not to interfere withthe patient's normal activities like swallowing and speech. The airwayimplant devices described herein may completely or partially open therelevant air passageways.

One or more implants are placed in the soft palate, sidewalls of theairway, around the trachea, in the tongue, in the uvula, or incombinations thereof. The implant has lead wires (e.g., anode andcathode) attached to the EAP element. In some embodiments, the leadwires are connected to an induction coil. The induction coil istypically implanted in the roof of the mouth. Preferably, the patientwears a retainer type of device before going to bed. The retainer has aninduction coil, a circuit and a battery. When the patient wears theretainer, the induction coil in the retainer is proximal to theinduction coil that is implanted in the roof of the mouth. The energy isthen transmitted through the tissue and to the coil that is in the roofof the mouth. When the EAP element is energized it deforms and/orstiffens to provide support to so as to completely or partially open theairways. In the morning when the patient wakes up, the patient removesthe retainer and places the retainer on a charging unit to recharge thebattery.

A first aspect of the invention is an airway implant device comprisingan electroactive polymer element which is adapted and configured tomodulate the opening of an air passageway. In some embodiments thedevice includes an anode and a cathode connected to the electroactivepolymer element, an inductor, and a controller. The controller can be amicroprocessor which is adapted and configured to sense the opening ofthe air passageway and control the energizing of the electroactivepolymer element. Other embodiments of the device include a non-implantedportion, such as a mouth guard. Preferably, the non-implanted portion isadapted and configured to control the electroactive polymer element. Thenon-implanted portion also typically includes a power supply and aninductor. The inductor in the implanted portion is adapted andconfigured to interact with the inductor in the implanted portion of thedevice. The device is preferably adapted and configured for implantationinto a soft palate and/or a lateral pharyngeal wall. In preferredembodiments, the electroactive polymer element comprises an ion-exchangepolymer metal composite. The functioning of the device is preferably byenergizing the electroactive polymer element which then causes acomplete or partial opening of the air passageway. Preferably, thedevice comprises an inductive coupling mechanism adapted to connect theelectroactive polymer element to a power source

Other aspects of the invention are methods of using the devicesdisclosed herein. One embodiment is a method of controlling an openingof an air passageway by implanting an airway implant device comprisingan electroactive polymer element proximal to an air passageway and/or ina wall of an air passageway and controlling the opening of the airpassageway by energizing the electroactive polymer element to completelyor partially open said air passageway. Preferably the control of theopening of the air passageway is in response to feedback from the airpassageway regarding the opening of the air passageway. The airwayimplant device can be implanted in a soft palate and/or a lateralpharyngeal wall. Preferably, the airway implant device is controlled byan inductive coupling mechanism. This method is preferably used to treatairway disorders such as obstructive sleep apnea or snoring.

Another embodiment is a method of treating a disease using an airwayimplant device comprising implanting an airway implant device with adeformable element in the soft palate of a patient and controlling theopening of the air passageway by energizing the deformable element. Theenergizing of the deformable element moves the soft palate to support acollapsed tongue or a tongue that has the tendency to collapse andcompletely or partially opens the air passageway. The deformable elementis preferably a non-magnetic material and even more preferably anelectroactive polymer.

Yet another embodiment is a method of treating a disease using an airwayimplant device comprising implanting an airway implant device with adeformable element in a lateral pharyngeal wall and controlling theopening of the air passageway by energizing the deformable element,wherein the energizing of the deformable element supports the lateralpharyngeal wall and completely or partially opens the air passageway.The deformable element is preferably a non-magnetic material and evenmore preferably an electroactive polymer.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of the airway implant device.

FIG. 2 illustrates one embodiment of the airway implant device.

FIG. 3 illustrates one embodiment of the airway implant device.

FIG. 4 illustrates one embodiment of the airway implant device.

FIG. 5 illustrates a circuit diagram of an embodiment of the airwayimplant device.

FIG. 6 illustrates an embodiment of the airway implant device.

FIG. 7 illustrates a sectional view of an embodiment of theelectroactive polymer element.

FIG. 8 illustrates a sectional view of an embodiment of theelectroactive polymer element.

FIG. 9 illustrates an embodiment of the electroactive polymer element.

FIG. 10 illustrates an embodiment of the electroactive polymer element.

FIG. 11 illustrates an embodiment of the electroactive polymer element.

FIG. 12 illustrates an embodiment of the electroactive polymer element.

FIG. 13 illustrates an embodiment of the electroactive polymer element.

FIG. 14 illustrates an embodiment of the electroactive polymer element.

FIG. 15 illustrates an embodiment of the electroactive polymer element.

FIG. 16 illustrates an embodiment of the electroactive polymer element.

FIG. 17 illustrates an embodiment of the electroactive polymer element.

FIG. 18 illustrates an embodiment of the electroactive polymer element.

FIG. 19 illustrates an embodiment of the electroactive polymer element.

FIG. 20 illustrates an embodiment of the implanted portion of the airwayimplant device.

FIG. 21 illustrates an embodiment of the airway implant device.

FIG. 22 illustrates an embodiment of the non-implanted portion in theform of a mouth guard.

FIG. 23 illustrates an embodiment of the non-implanted portion in theform of a mouth guard.

FIG. 24 illustrates an embodiment of the non-implanted portion.

FIG. 25 shows a sagittal section through a head of a subjectillustrating an embodiment of a method for using the airway implantdevice.

FIG. 26 illustrates an anterior view of the mouth with see-through mouthroofs to depict an embodiment of a method for using the airway implantdevice.

FIG. 27 illustrates an anterior view of the mouth with see-through mouthroofs to depict an embodiment of a method for using the airway implantdevice.

FIG. 28 illustrates an anterior view of the mouth with see-through mouthroofs to depict an embodiment of a method for using the airway implantdevice.

FIG. 29 illustrates an anterior view of the mouth with see-through mouthroofs to depict an embodiment of a method for using the airway implantdevice.

FIG. 30 illustrates an embodiment of an inductive coupling systemassociated with the airway implant device.

FIG. 31 illustrates an embodiment of the airway implant device.

FIG. 32 illustrates an embodiment of the airway implant device.

FIG. 33 illustrates an embodiment in which a patient wears thenon-implanted portion of the device on the cheeks.

FIG. 34A-34B illustrate an embodiment of a method of the invention withthe airway implant in the soft palate.

FIG. 35A-35B illustrate an embodiment of a method of the invention withthe airway implants in the soft palate and lateral pharyngeal walls.

FIG. 36A-36B illustrate an embodiment of a method of the invention withthe airway implants in the lateral pharyngeal walls.

DETAILED DESCRIPTION

Devices and Methods

A first aspect of the invention is a device for the treatment ofdisorders associated with improper airway patency, such as snoring orsleep apnea. The device comprises of a deformable element to adjust theopening of the airway. In a preferred embodiment, the deformable elementcomprises of an electroactive polymer (EAP) element. The electroactivepolymer element in the device assists in maintaining appropriate airwayopening to treat the disorders. Typically, the EAP element providessupport for the walls of an airway, when the walls collapse, and thus,completely or partially opens the airway.

The device functions by maintaining energized and non-energizedconfigurations of the EAP element. In preferred embodiments, duringsleep, the EAP element is energized with electricity to change its shapeand thus modify the opening of the airway. Typically, in thenon-energized configuration the EAP element is soft and in the energizedconfiguration is stiffer. The EAP element of the device can have apre-set non-energized configuration wherein it is substantially similarto the geometry of the patient's airway where the device is implanted.

In some embodiments, the device, in addition to the EAP element,includes an implantable transducer in electrical communication with theEAP element. A conductive lead connects the EAP element and theimplantable transducer to the each other. The device of the presentinvention typically includes a power supply in electrical communicationwith the EAP element and/or the implantable transducer, such as abattery or a capacitor. The battery can be disposable or rechargeable.

Preferred embodiments of the invention include a non-implanted portion,such as a mouthpiece, to control the implanted EAP element. Themouthpiece is typically in conductive or inductive communication with animplantable transducer. In one embodiment, the mouthpiece is a dentalretainer with an induction coil and a power source. The dental retainercan further comprise a pulse-width-modulation circuit. When a dentalretainer is used it is preferably custom fit for the individualbiological subject. If the implantable transducer is in inductivecommunication, it will typically include an inductive receiver, such asa coil. The implantable transducer can also include a conductivereceiver, such as a dental filling, a dental implant, an implant in theoral cavity, an implant in the head or neck region. In one embodiment,the device includes a dermal patch with a coil, circuit and powersource, in communication with the implantable transducer. The dermalpatch can also include a pulse-width-modulation circuit.

Another aspect of the invention is a method to modulate air flow throughairway passages. Such modulation is used in the treatment of diseasessuch as snoring and sleep apnea. One method of the invention is a methodfor modulating the airflow in airway passages by implanting in a patienta device comprising a deformable element and controlling the device byenergizing the deformable element. The deformable element preferablycomprises an electroactive polymer element. The deformable element canbe controlled with a mouthpiece inserted into the mouth of the patient.The energizing is typically performed with the use of a power supply inelectrical communication, either inductive communication or conductivecommunication, with the deformable element. A transducer can be used toenergize the deformable element by placing it in electricalcommunication with the power supply. Depending on the condition beingtreated, the deformable element is placed in different locations such assoft palate, airway sidewall, uvula, pharynx wall, trachea wall, larynxwall, and/or nasal passage wall.

A preferred embodiment of the device of the present invention comprisesan implantable deformable element; an implantable transducer; animplantable lead wire connecting the deformable element and thetransducer; a removable transducer; and a removable power source; andwherein the deformable element comprises an electroactive polymer.

Electroactive polymer is a type of polymer that responds to electricalstimulation by physical deformation, change in tensile properties,and/or change in hardness. There are several types of electroactivepolymers like dielectric electrostrictive polymer, ion exchange polymerand ion exchange polymer metal composite (IPMC). The particular type ofEAP used in the making of the disclosed device can be any of theaforementioned electroactive polymers.

Suitable materials for the electroactive polymer element include, butare not limited to, an ion exchange polymer, an ion exchange polymermetal composite, an ionomer base material. In some embodiments, theelectroactive polymer is perfluorinated polymer such aspolytetrafluoroethylene, polyfluorosulfonic acid, perfluorosulfonate,and polyvinylidene fluoride. Other suitable polymers includepolyethylene, polypropylene, polystyrene, polyaniline,polyacrylonitrile, cellophane, cellulose, regenerated cellulose,cellulose acetate, polysulfone, polyurethane, polyvinyl alcohol,polyvinyl acetate, polyvinyl pyrrolidone. Typically, the electroactivepolymer element includes a biocompatible conductive material such asplatinum, gold, silver, palladium, copper, and/or carbon.

Suitable shapes of the electroactive polymer element include threedimensional shape, substantially rectangular, substantially triangular,substantially round, substantially trapezoidal, a flat strip, a rod, acylindrical tube, an arch with uniform thickness or varying thickness, ashape with slots that are perpendicular to the axis, slots that areparallel to the longitudinal axis, a coil, perforations, and/or slots.

IPMC is a polymer and metal composite that uses an ionomer as the basematerial. Ionomers are types of polymers that allow for ion movementthrough the membrane. There are several ionomers available in the marketand some of the suited ionomers for this application are polyethylene,polystyrene, polytetrafluoroethylene, polyvinylidene fluoride,polyfluorosulfonic acid based membranes like NAFION® (from E. I. Du Pontde Nemours and Company, Wilmington, Del.), polyaniline,polyacrylonitrile, cellulose, cellulose acetates, regenerated cellulose,polysulfone, polyurethane, or combinations thereof. A conductive metal,for example gold, silver, platinum, palladium, copper, carbon, orcombinations thereof, can be deposited on the ionomer to make the IPMC.The IPMC element can be formed into many shapes, for example, a strip,rod, cylindrical tube, rectangular piece, triangular piece, trapezoidalshape, arch shapes, coil shapes, or combinations thereof. The IPMCelement can have perforations or slots cut in them to allow tissue ingrowth.

The electroactive polymer element has, in some embodiments, multiplelayers of the electroactive polymer with or without an insulation layerseparating the layers of the electroactive polymer. Suitable insulationlayers include, but are not limited to, silicone, polyurethane,polyimide, nylon, polyester, polymethylmethacrylate,polyethylmethacrylate, neoprene, styrene butadiene styrene, or polyvinylacetate.

In some embodiments, the deformable element, the entire device, orportions of the airway implant have a coating. The coating isolates thecoated device from the body fluids and/or tissue either physically orelectrically. The device can be coated to minimize tissue growth orpromote tissue growth. Suitable coatings include poly-L-lysine,poly-D-lysine, polyethylene glycol, polypropylene, polyvinyl alcohol,polyvinylidene fluoride, polyvinyl acetate, hyaluronic acid, and/ormethylmethacrylate.

Embodiments of the Device

FIG. 1 illustrates an airway implant system 2 that has a power supply 4,a connecting element, such as a wire lead 14, and a deformable element,such as an electroactive polymer element 8. Suitable power supplies 4are a power cell, a battery, a capacitor, a substantially infinite bus(e.g., a wall outlet leading to a power generator), a generator (e.g., aportable generator, a solar generator, an internal combustiongenerator), or combinations thereof. The power supply 4 typically has apower output of from about 1 mA to about 5 A, for example about 500 mA.

Instead of or in addition to wire lead 14, the connecting element may bean inductive energy transfer system, a conductive energy transfersystem, a chemical energy transfer system, an acoustic or otherwisevibratory energy transfer system, a nerve or nerve pathway, otherbiological tissue, or combinations thereof. The connecting element ismade from one or more conductive materials, such as copper. Theconnecting element is completely or partially insulated and/or protectedby an insulator, for example polytetrafluoroethylene (PTFE). Theinsulator can be biocompatible. The power supply 4 is typically inelectrical communication with the deformable element 8 through theconnecting element. The connecting element is attached to an anode 10and a cathode 12 on the power supply 4. The connecting elements can bemade from one or more sub-elements.

The deformable element 8 is preferably made from an electroactivepolymer. Most preferably, the electroactive polymer is an ion exchangepolymer metal composite (IPMC). The IPMC has a base polymer embedded, orotherwise appropriately mixed, with a metal. The IPMC base polymer ispreferably perfluoronated polymer, polytetrafluoroethylene,polyfluorosulfonic acid, perfluorosulfonate, polyvinylidene fluoride,hydrophilic polyvinylidene fluoride, polyethylene, polypropylene,polystyrene, polyaniline, polyacrylonitrile, cellophane, cellulose,regenerated cellulose, cellulose acetate, polysulfone, polyurethane,polyvinyl alcohol, polyvinyl acetate and polyvinyl pyrrolidone, orcombinations thereof. The IPMC metal can be platinum, gold, silver,palladium, copper, carbon, or combinations thereof.

FIG. 2 illustrates that the deformable element 8 can have multipleelements 8 and connecting elements 14 that all connect to a single powersupply 4.

FIG. 3 illustrates an airway implant system 2 with multiple powersupplies 4 and connecting elements 14 that all connect to a singledeformable element 8. The airway implant system 2 can have any numberand combination of deformable elements 8 connected to power supplies 4.

FIG. 4 illustrates an embodiment with the connecting element having afirst energy transfer element, for example a first transducer such as afirst receiver, and a second energy transfer element, for example asecond transducer such as a second inductor 16. In this embodiment, thefirst receiver is a first inductor 18. The first inductor 18 istypically positioned close enough to the second inductor 16 to enablesufficient inductive electricity transfer between the second and firstinductors 16 and 18 to energize the deformable element 8. The connectingelement 14 has multiple connecting elements 6.

FIG. 5 illustrates that the airway implant device of the presentinvention can have an implanted portion 20 and a non-implanted portion22. In this embodiment, the implanted portion 20 is a closed circuitwith the first inductor 18 in series with a first capacitor 24 and thedeformable element 8. The deformable element 8 is attached to the closedcircuit of the implanted portion 20 by a first contact 26 and a secondcontact 28. In some embodiments, the implanted portion has a resistor(not shown). The non-implanted portion 22 is a closed circuit. Thenon-implanted portion 22 has a second inductor 16 that is in series witha resistor 30, the power supply 4, and a second capacitor 32. Thecapacitors, resistors, and, in-part, the inductors are representative ofthe electrical characteristics of the wire of the circuit and notnecessarily representative of specific elements. The implanted portion20 is within tissue and has a tissue surface 33 nearby. Thenon-implanted portion is in insulation material 35. An air interface 37is between the tissue surface 33 and the insulation material 35.

FIG. 6 illustrates an embodiment in which the first energy transferelement of the connecting element 14 is a first conductor 34. The secondenergy transfer element of the connecting element 14 is a secondconductor 36. The first conductor 34 is configured to plug into,receive, or otherwise make secure electrical conductive contact with thesecond conductor 36. The first conductor 34 and/or second conductor 36are plugs, sockets, conductive dental fillings, tooth caps, fake teeth,or any combination thereof.

FIG. 7 illustrates an embodiment in which the deformable element 8 is amulti-layered device. The deformable element 8 has a first EAP layer 38,a second EAP layer 40, and a third EAP layer 42. The EAP layers 38, 40and 42 are in contact with each other and not separated by an insulator.

FIG. 8 illustrates another embodiment in which the deformable element 8has a first EAP layer 38 separated from a second EAP layer 40 by a firstinsulation layer 44. A second insulation layer 46 separates the secondEAP layer from the third EAP layer 42. A third insulation layer 48separates the third EAP layer from the fourth EAP layer 50. Insulationmaterial is preferably a polymeric material that electrically isolateseach layer. The insulation can be, for example, acrylic polymers,polyimide, polypropylene, polyethylene, silicones, nylons, polyesters,polyurethanes, or combinations thereof. Each EAP layer, 38, 40, 42 and50 can be connected to a lead wire (not shown). All anodes and allcathodes are connected to the power supply 4.

FIGS. 9-19 illustrate different suitable shapes for the deformableelement 8. FIG. 9 illustrates a deformable element 8 with asubstantially flat rectangular configuration. The deformable element 8can have a width from about 2 mm to about 5 cm, for example about 1 cm.FIG. 10 illustrates a deformable element 8 with an “S” or zig-zag shape.FIG. 11 illustrates the deformable element 8 with an oval shape. FIG. 12illustrates a deformable element 8 with a substantially flat rectangularshape with slots 52 cut perpendicular to the longitudinal axis of thedeformable element 8. The slots 52 originate near the longitudinal axisof the deformable element 8. The deformable element 8 has legs 54extending away from the longitudinal axis. FIG. 13 illustrates adeformable element 8 with slots 52 and legs 54 parallel with thelongitudinal axis. FIG. 14 illustrates a deformable element beconfigured as a quadrilateral, such as a trapezoid. The deformableelement 8 has chamfered corners, as shown by radius. FIG. 15 illustratesa deformable element 8 with apertures 55, holes, perforations, orcombinations thereof. FIG. 16 illustrates a deformable element 8 withslots 52 and legs 54 extending from a side of the deformable element 8parallel with the longitudinal axis. FIG. 17 illustrates a deformableelement 8 with a hollow cylinder, tube, or rod. The deformable elementhas an inner diameter 56. FIG. 18 illustrates an arched deformableelement 8. The arch has a radius of curvature 57 from about 1 cm toabout 10 cm, for example about 4 cm. The deformable element 8 has auniform thickness. FIG. 19 illustrates an arched deformable element 8.The deformable element 8 can have a varying thickness. A first thickness58 is equal or greater than a second thickness 60.

FIG. 20 illustrates an embodiment of the implanted portion of an airwayimplant with a coil-type inductor 18 connected by a wire lead 6 to thedeformable element 8. In another embodiment, as illustrated in FIG. 21the implanted portion has a conductive dental filling 62 in a tooth 64.The dental filling 62 is previously implanted for reasons related orunrelated to using of the airway implant system. The dental filling 62is electrically connected to the wire lead 6. For example, a portion ofthe wire lead 6 is implanted in the tooth 64, as shown by phantom line.The wire lead 6 is connected to the deformable element 8.

FIG. 22 illustrates an embodiment of the non-implanted portion 22 with amouthpiece, such as a retainer 66. The retainer 66 is preferably customconfigured to fit to the patient's mouth roof, or another part of thepatient's mouth. The second transducer, such as second inductor 16, isintegral with, or attached to, the retainer 66. The second inductor 16is located in the retainer 66 so that during use the second inductor 16is proximal with the first inductor 18. The power supply 4, such as acell, is integral with, or attached to, the retainer 66. The powersupply 4 is in electrical communication with the second inductor 16. Insome embodiments, the retainer 66 has a pulse-width-modulation circuit.FIG. 23 illustrates that the retainer 66 has one or more tooth sockets68. The tooth sockets 68 are preferably configured to receive teeth thathave dental fillings. The tooth sockets 68 are electrically conductivein areas where they align with dental fillings when in use. The powersupply 4 is connected with the tooth sockets 68 via the wire leads 6. Inthe embodiment of FIG. 24, the non-implantable portion 22 has the secondinductor 16 attached to a removably attachable patch 70. The patch 70 isattached to the power supply 4. The power supply 4 is in contact withthe second inductor 16. This embodiment can be, for example, located onthe cheeks as shown on FIG. 33 or any other suitable location.

Preferably, the airway implant device 2 discussed herein is used incombination with an inductive coupling system 900 such as depicted inFIG. 30. FIG. 30 depicts an inductive coupling system that is suitablefor controlling the airway implant device 2 which includes a connectingelement 906 (which connects the electrical contacts (not shown) to therest of the electrical system), a connector 901, a energy source 322, asensor 903, a timer 904, and a controller 905. The connector 901, energysource 322, sensor 903, a timer 904, and controller 905 are located in ahousing disposed in a region outside or inside the body.

Two preferred embodiments of the airway implant device are shown inFIGS. 31 and 32. The device in FIG. 31 includes the deformable element 8connected to an anode 10 and cathode 12 and to the induction coil 18.The device also includes a controller 90, such as a microprocessor. Thecircuitry within the controller is not shown. The controller 90 picks upAC signals from the induction coil 18 and converts it to DC current. Thecontroller 90 can also include a time delay circuit and/or a sensor. Thesensor could sense the collapsing and/or narrowing of the airways andcause the device to energize the deformable element 8 and thuscompletely or partially open up the airway in which the device isimplanted. FIG. 32 shows an embodiment with anchors 91 located on thedeformable element 8. The implant can be anchored in a suitable locationwith the use of these anchors and sutures and/or surgical glue.

The implants described herein are preferably implanted with a deploymenttool. Typically, the implantation involves an incision, surgicalcavitation, and/or affixing the implant.

Methods of Making Electroactive Polymer Element

In some embodiments, the EAP element is an IPMC strip which is made froma base material of an ionomer sheet, film or membrane. The ionomer sheetis formed using ionomer dispersion.

IPMC is made from the base ionomer of, for example, polyethylene,polystryrene, polytetrafluoroethylene, polyvinylidene fluoride (PVDF)(e.g., KYNAR® and KYNAR Flex®, from ATOFINA, Paris, France, and SOLEF®,from Solvay Solexis S.A., Brussels, Belgium), hydrophilic-PVDF (h-PVDF),polyfluorosulfonic acid based membranes like NAFION® (from E.I. Du Pointde Nemours and Company, Wilmington, Del.), polyaniline,polyacrylonitrile, cellulose, cellulose acetates, regenerated cellulose,polysulfone, polyurethane, and combinations thereof. The conductivematerial that is deposited on the ionomer can be gold, platinum, silver,palladium, copper, graphite, conductive carbon, or combinations thereof.Conductive material is deposited on the ionomer either by electrolysisprocess, vapor deposition, sputtering, electroplating, or combination ofprocesses.

The IPMC is cut into the desired implant shape for the EAP element. Theelectrical contact (e.g., anode and cathode wires for EAP element) isconnected to the IPMC surfaces by, for example, soldering, welding,brazing, potting using conductive adhesives, or combinations thereof.The EAP element is configured, if necessary, into specific curved shapesusing mold and heat setting processes.

In some embodiments, the EAP element is insulated with electricalinsulation coatings. Also, the EAP element can be insulated withcoatings that promote cell growth and minimize fibrosis, stop cellgrowth, or kill nearby cells. The insulation can be a biocompatiblematerial. The EAP element is coated with polymers such as polypropylene,poly-L-lysine, poly-D-lysine, polyethylene glycol, povinyl alcohol,polyvinyl acetate, polymethyl methacrylate, or combinations thereof. TheEAP element can also be coated with hyaluronic acid. The coating isapplied to the device by standard coating techniques like spraying,electrostatic spraying, brushing, vapor deposition, dipping, etc.

In one example, a perfluorosulfonate ionomer, PVDF or h-PVDF sheet isprepared for manufacturing the EAP element. In an optional step, thesheet is roughened on both sides using, for example, about 320 grit sandpaper and then about 600 grit sand paper; then rinsed with deionizedwater; then submerged in isopropyl alcohol (IPA); subjected to anultrasonic bath for about 10 minutes; and then the sheet is rinsed withdeionized water. The sheet is boiled for about 30 minutes inhydrochloric acid (HCL). The sheet is rinsed and then boiled indeionized water for about 30 minutes. The sheet is then subject toion-exchange (i.e., absorption). The sheet is submerged into, orotherwise exposed to, a metal salt solution at room temperature for morethan about three hours. Examples of the metal salt solution aretetraammineplatinum chloride solution, silver chloride solution,hydrogen tetrachloroaurate, tetraamminepalladium chloride monohydrate orother plantinum, gold, silver, carbon, copper, or palladium salts insolution. The metal salt solution typically has a concentration ofgreater than or equal to about 200 mg/100 ml water. 5% ammoniumhydroxide solution is added at a ratio of 2.5 ml/100 ml to thetetraammineplatinum chloride solution to neutralize the solution. Thesheet is then rinsed with deionized water. A primary plating is thenapplied to the sheet. The sheet is submerged in water at about 40° C. A5% solution by weight of sodium borohydride and deionized water is addedto the water submerging the sheet at 2 ml/180 ml of water. The solutionis stirred for 30 minutes at 40° C. The sodium borohydride solution isthen added to the water at 2 ml/180 ml of water and the solution isstirred for 30 minutes at 40° C. This sodium borohydride adding andsolution stirring is performed six times total. The water temperature isthen gradually raised to 60° C. 20 ml of the sodium borohydride solutionis then added to the water. The solution is stirred for about 90minutes. The sheet is then rinsed with deionized water, submerged into0.1N HCI for an hour, and then rinsed with deionized water.

In some embodiments, the sheet receives a second plating. The sheet issubmerged or otherwise exposed to a tetraammineplatinum chloridesolution at a concentration of about 50 mg/100 ml deionized water. 5%ammonium hydroxide solution is added at a rate of 2 ml/100 ml oftetrammineplatinum chloride solution. 5% by volume solution ofhydroxylamine hydrochloride in deionized water is added to thetetraammineplantium chloride solution at a ratio of 0.1 of the volume ofthe tetraammineplatinum chloride solution. 20% by volume solution ofhydrazine monohydrate in deionized water is added to thetetraammineplatinum chloride solution at a ratio of 0.05 of the voluneof the tetraammineplantinum chloride solution. The temperature is thenset to about 40° C. and the solution is stirred.

A 5% solution of hydroxylamine hydrochloride is then added at a ratio of2.5 m/100 ml of tetraammineplatinum chloride solution. A 20% solution ofhydrazine monohydrate solution is then added at a ratio of 1.25 m/100 mltetraammineplatinum chloride solution. The solution is stirred for 30minutes and the temperature set to 60° C. The above steps in thisparagraph can be repeated three additional times. The sheet is thenrinsed with deionized water, boiled in HCl for 10 minutes, rinsed withdeionized water and dried.

In some embodiments, the polymer base is dissolved in solvents, forexample dimethyl acetamide, acetone, methylethyle ketone, toluene,dimethyl carbonate, diethyl carbonate, and combinations thereof. Thesolvent is then allowed to dry, producing a thin film. While thesolution is wet, a low friction, (e.g., glass, Teflon) plate is dippedinto the solution and removed. The coating on the plate dries, creatinga think film. The plate is repeatedly dipped into the solution toincrease the thickness of the film.

Polyvinyl alcohol, polyvinyl pyrrolidone, polyinyl acetate orcombinations thereof can be added to a PVDF solution before drying, thuscontributing hydrophilic properties to PVDF and can improve ionmigration through the polymer film during manufacture. Dye or othercolor pigments can be added to the polymer solution.

Method of Using

FIG. 25 illustrates an embodiment of a method of the airway implantdevice of the present invention. In this embodiment, the first inductor18 is implanted in the mouth roof 72, for example in or adjacent to thehard palate 74. Wire leads 6 connect the first inductor 18 to thedeformable elements 8 a, 8 b, and 8 c. A first deformable element 8 a isimplanted in the base of the tongue at the pharynx wall 76. A seconddeformable element 8 b is integral with the first deformable element 8 a(e.g., as two sections of a hollow cylindrical deformable element 8,such as shown in FIG. 17). The first and second deformable elements 8 aand 8 b can be separate and unattached elements. The third deformableelement 8 c is implanted in the uvula and/or soft palate 84. Thedeformable elements 8 can also be implanted in the wall of the nasalpassages 78, higher or lower in the pharynx 79, such as in the nasalpharynx, in the wall of the trachea 80, in the larynx (not shown), inany other airway, or combinations thereof. The second inductor 16 isworn by the patient in the mouth 82. The second inductor 16 is connectedto an integral or non-integral power supply. The second inductor 16comprises one or multiple induction coils. The second inductor 16inductively transmits RF energy to the first inductor 18. The firstinductor 18 changes the RF energy into electricity. The first inductor18 sends a charge or current along the wire leads 6 to the deformableelements 8 a, 8 b, and 8 c. The deformable elements 8 a, 8 b, and 8 care energized by the charge or current. The energized deformableelements 8 a, 8 b, and 8 c increase the stiffness and/or alter the shapeof the airways. The energized deformable elements 8 a, 8 b, and 8 cmodulate the opening of the airways around which the deformable elements8 a, 8 b, and 8 c are implanted. The non-energized deformable elements 8a, 8 b, and 8 c are configured to conform to the airway around which thedeformable elements 8 a, 8 b, and 8 c are implanted. The non-energizeddeformable elements 8 a, 8 b, and 8 c are flexible and soft.

FIG. 26 illustrates another embodiment of the invention. In thisembodiment, the first inductor 18 is implanted in the mouth roof 72 andattached to a deformable element 8 via the wire lead 6. The deformableelement 8 is preferably in the soft palate 84. In another embodiment,FIG. 27 illustrates that the first inductor 18 is implanted in the mouthroof 72 and attached to two deformable elements 8 via two wire leads 6.The deformable elements 8 are implanted in side walls 86 of the mouth82. In yet another embodiment, as illustrated in FIG. 28, the firstinductor 18 is implanted in the mouth roof 72 and attached to threedeformable elements 8 via three wire leads 6. The deformable elements 8are implanted in the soft palate 84 and the side walls 86 of the mouth82. FIG. 29 illustrates an embodiment in which the first conductors (notshown, e.g., the tooth sockets), are attached to, and in conductiveelectrical communication with, the second conductors. The retainer 66,such as shown in FIG. 23, can be worn by the patient to energize thedeformable element 8. The tooth sockets are removably attached to thefirst conductors 34. The first conductors 34 are dental fillings,conductive posts adjacent to and/or through the teeth 64.

FIG. 33 illustrates an embodiment in which a patient 88 has the firsttransducer (not shown) implanted in the patient's cheek and wears thenon-implanted portion 22, such as shown in FIG. 24, on the outside ofthe patient's cheek. The non-implanted portion 22 energizes theimplanted portion (not shown).

FIGS. 34-36 depict some of the ways in which the implant devicesfunction to open the airways. FIGS. 34A and 34B depict a side view of apatient with a soft palate implant 8 c and a non-implanted portion ofthe device, with a second inductor 16, which in this case is a wearablemouth piece. The wearable mouth piece includes a transmitter coil, apower source, and other electronics, which are not depicted. Also, shownis a first inductor 18. The implant device has the ability to sense anddeflect the tongue so as to open the airway. FIG. 34A depicts the tongue92 in its normal state. During sleep, when the tongue collapses 92′, asshown in FIG. 34B, the deformable element 8 c′ senses the collapsedtongue and is energized via the mouthpiece and first inductor and itstiffens to push away the tongue from the airway and keeps the airwayopen. This opening of the airway can be partial or complete. In someembodiments, particularly the embodiments without the sensor, theimplant is powered when the patient is asleep such that the deformableelement 8 is energized and keeps the collapsed tongue away from theairway.

FIGS. 35 and 36 depict an embodiment of keeping the airways open withlateral wall implants. FIG. 35A shows a side view of a patient's facewith a deformable element 8 located in the lateral wall of the airway.FIG. 35A depicts the tongue 92 in its normal state. FIG. 35B depicts thetongue 92′ in a collapsed state. When the tongue is in this state orbefore it goes into the collapsed state the deformable element 8 isenergized so as to stretch the lateral walls and open the airway, asshown in FIG. 36B. FIGS. 36A and 36B are a view of the airway as seenthrough the mouth of patient. FIG. 36 A depicts the deformable elements8 in a non-energized state and the tongue in a non-collapsed state. Whenthe tongue collapses or it has a tendency to collapse, such as duringsleep, the deformable element 8 is energized and airway walls are pushedaway from the tongue and creates an open air passageway 93. Thisembodiment is particularly useful in obese patients.

Airway Diseases

During sleep, the muscles in the roof of the mouth (soft palate), tongueand throat relax. If the tissues in the throat relax enough, theyvibrate and may partially obstruct the airway. The more narrowed theairway, the more forceful the airflow becomes. Tissue vibrationincreases, and snoring grows louder. Having a low, thick soft palate orenlarged tonsils or tissues in the back of the throat (adenoids) cannarrow the airway. Likewise, if the triangular piece of tissue hangingfrom the soft palate (uvula) is elongated, airflow can be obstructed andvibration increased. Being overweight contributes to narrowing of throattissues. Chronic nasal congestion or a crooked partition between thenostrils (deviated nasal septum) may be to blame.

Snoring may also be associated with sleep apnea. In this seriouscondition, excessive sagging of throat tissues causes your airway tocollapse, preventing breathing. Sleep apnea generally breaks up loudsnoring with 10 seconds or more of silence. Eventually, the lack ofoxygen and an increase in carbon dioxide signal causes the person towake up, forcing the airway open with a loud snort.

Obstructive sleep apnea occurs when the muscles in the back of thethroat relax. These muscles support the soft palate, uvula, tonsils andtongue. When the muscles relax, the airway is narrowed or closed duringbreathing in, and breathing is momentarily cut off. This lowers thelevel of oxygen in the blood. The brain senses this decrease and brieflyrouses the person from sleep so that the airway can be reopened.Typically, this awakening is so brief that it cannot be remembered.Central sleep apnea, which is far less common, occurs when the brainfails to transmit signals to the breathing muscles.

Thus, it can be seen that airway disorders, such as sleep apnea andsnoring, are caused by improper opening of the airway passageways. Thedevices and methods described herein are suitable for the treatment ofdisorders caused by the improper opening of the air passageways. Thedevices can be implanted in any suitable location such as to open up theairways. The opening of the passageways need not be a complete openingand in some conditions a partial opening is sufficient to treat thedisorder.

In addition to air passageway disorders, the implants disclosed hereinare suitable for use in other disorders. The disorders treated with thedevices include those that are caused by improper opening and/or closingof passageways in the body, such as various locations of thegastrointestinal tract or blood vessels. The implantation of the devicesare suitable for supporting walls of passageways The devices can beimplanted in the walls of the gastrointestinal tract, such as theesophagus to treat acid reflux.

It is apparent to one skilled in the art that various changes andmodifications can be made to this disclosure, and equivalents employed,without departing from the spirit and scope of the invention. Elementsshown with any embodiment are exemplary for the specific embodiment andcan be used on other embodiments within this disclosure.

1. An airway implant device comprising an electroactive polymer element,wherein said electroactive polymer element is adapted and configured tomodulate an opening of an air passageway.
 2. The device of claim 1further comprising an anode, a cathode, a first inductor, and acontroller; said anode and cathode being connected to said electroactivepolymer element.
 3. The device of claim 2 wherein said controllercomprises a microprocessor, said microprocessor being adapted andconfigured to sense said opening of said air passageway and controllingan energizing of said electroactive polymer element.
 4. The device ofclaim 1 further comprising a non-implanted portion.
 5. The device ofclaim 4 wherein said non-implanted portion is a mouth guard, said mouthguard being adapted and configured to control said electroactive polymerelement.
 6. The device of claim 5 wherein said mouth guard comprises apower supply and a second inductor.
 7. The device of claim 6 whereinsaid second inductor is adapted and configured to interact with saidfirst inductor.
 8. The device of claim 1 wherein said electroactivepolymer element is adapted and configured for implantation into a softpalate and/or a lateral pharyngeal wall.
 9. The device of claim 1wherein said electroactive polymer element comprises an ion-exchangepolymer metal composite.
 10. The device of claim 1 wherein theelectroactive polymer element comprises a substantially flat surface.11. The device of claim 1 further comprising a power supply inelectrical communication with the electroactive polymer element.
 12. Thedevice of claim 1 wherein application of electrical current to saidelectroactive polymer element opens an air passageway.
 13. The device ofclaim 1 further comprising a coating to prevent tissue growth.
 14. Thedevice of claim 1 further comprising a coating to promote tissue growth.15. The device of claim 1 further comprising an inductive couplingmechanism adapted to connect the electroactive polymer element to apower source.
 16. A method of controlling an opening of an airpassageway comprising: implanting an airway implant device proximal toan air passageway and/or in a wall of an air passageway, said devicecomprising an electroactive polymer element and a power managementdevice; controlling an opening of said air passageway, said controlbeing performed by energizing said electroactive polymer element tocompletely or partially open said air passageway.
 17. The method ofclaim 16 wherein said control of said opening of said air passageway isin response to feedback from said air passageway, said feedback beingrelated to said opening of said air passageway.
 18. The method of claim16 wherein said airway implant device is implanted in a soft palateand/or a lateral pharyngeal wall.
 19. The method of claim 16 whereinsaid airway implant device is coated with an agent to prevent tissuegrowth around said airway implant device.
 20. The method of claim 16wherein said airway implant device is coated with an agent to promotetissue growth around said airway implant device.
 21. The method of claim16 wherein said airway implant device is controlled by an inductivecoupling mechanism.
 22. A method of treating a disease using an airwayimplant device comprising: implanting an airway implant device proximalto an air passageway and/or in a wall of an air passageway, said airwayimplant device comprising an electroactive polymer element; controllingan opening of said air passageway by energizing said electroactivepolymer element, wherein said energizing of said electroactive polymerelement completely or partially opens said air passageway.
 23. Themethod of claim 22 wherein said disease is obstructive sleep apnea orsnoring.
 24. The method of claim 22 wherein said airway implant deviceis controlled by an inductive coupling mechanism.
 25. A method oftreating a disease using an airway implant device comprising: implantingan airway implant device in a soft palate, said airway implant devicecomprising an electroactive polymer element; controlling an opening ofan air passageway by energizing said electroactive polymer element,wherein said energizing of said electroactive polymer element moves saidsoft palate to support a collapsed tongue and completely or partiallyopens said air passageway.
 26. A method of treating a disease using anairway implant device comprising: implanting an airway implant device ina lateral pharyngeal wall, said airway implant device comprising anelectroactive polymer element; controlling an opening of an airpassageway by energizing said electroactive polymer element, whereinsaid energizing of said electroactive polymer supports said lateralpharyngeal wall and completely or partially opens said air passageway.27. A method of treating a disease using an airway implant devicecomprising: implanting an airway implant device in a soft palate,wherein said airway implant device comprises a deformable element;controlling an opening of an air passageway by energizing saiddeformable element, wherein said energizing of said deformable elementmoves said soft palate to support a collapsed tongue and completely orpartially opens said air passageway.
 28. The method of claim 27 whereinsaid deformable element comprises a non-magnetic material.
 29. Themethod of claim 27 wherein said deformable element comprises anelectroactive polymer element.
 30. A method of treating a disease usingan airway implant device comprising: implanting an airway implant devicein a lateral pharyngeal wall, said airway implant device comprising adeformable element; controlling an opening of an air passageway byenergizing said a deformable element, wherein said energizing of said adeformable element supports said lateral pharyngeal wall and completelyor partially opens up said air passageway.
 21. The method of claim 30wherein said deformable element comprises a non-magnetic material. 32.The method of claim 30 wherein said deformable element comprises anelectroactive polymer element.